Effect of Chromium Weight Reduction on Adult Asthma Control
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Asthma exacerbation frequency
研究概览
简要总结
This phase IV randomized controlled trial is designed to evaluate the effects of chromium picolinate supplementation in obese adults with stable asthma. A total of 60 participants will be recruited from Ain Shams University Hospitals and randomly assigned to receive either 400 mcg of chromium picolinate daily or a matching placebo for 12 weeks, in addition to standard asthma therapy.
The study aims to explore the interaction between metabolic dysfunction and asthma, as obesity-related asthma is often associated with systemic inflammation, insulin resistance, and dyslipidemia. These factors may contribute to poorer asthma control and impaired pulmonary function, and therefore represent potential targets for adjunctive therapeutic interventions such as chromium supplementation.
详细描述
Study Design and Setting This study is a phase IV randomized controlled clinical trial (RCT) involving 60 adult patients diagnosed with asthma. Participants will be recruited from the outpatient clinic and pulmonary function unit of the Chest Department at Ain Shams University Hospitals.
Study Type: Phase IV randomized controlled clinical trial (RCT) Study Setting: Outpatient clinic and pulmonary function unit, Chest Department, Ain Shams University Hospitals Study Population: Adult patients with asthma, obesity, and diabetes mellitus
Sampling and Randomization Participants will be randomly assigned to study groups using computer-generated randomization sequences. Allocation concealment will be ensured through the use of sealed, opaque envelopes.
Ethical Considerations
The study protocol will be explained clearly to all eligible participants prior to enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-65 years
- •Confirmed asthma diagnosis according to GINA criteria (7)
- •Asthma stable for at least 4 weeks (no acute exacerbation)
- •BMI of 30 kg/m² (obese category)
- •Stable inhaled corticosteroid + LABA regimen in the last 4 weeks
- •The patient is compliant on his asthma medication
- •Willing and able to provide informed consent
- •willing to continue in the study, follow investigator instructions
排除标准
- •- Recent asthma exacerbation (within the last 4 weeks)
- •Any change in asthma medications within 4 weeks
- •renal or hepatic disease
- •Use of lipid-lowering drugs or supplements in the past 3 months
- •Use of Vitamin C, prostaglandin inhibitors, such as aspirin, oxalate, and antacids
- •Current pregnancy or lactation
- •Known allergy to chromium or adverse reaction to supplementation
- •Participation in another interventional study in the past month
- •History of heavy metal toxicity or chromium sensitivity
- •Being on any weight control diet
- •Being on a supplement containing chromium
研究组 & 干预措施
Chromium Picolinate
Two tablets collectively containing 400 mcg of Chromium picolinate which is equivalent to 49.4 mcg of elemental chromium.
Taken once daily for 12 weeks.
干预措施: Chromium picolinate (Dietary Supplement)
Standard of Care
All participants continue standard asthma therapy and management
- Study participants will be instructed to keep their dietary consumption of chromium rich foods constant all over the study period.
结局指标
主要结局
Asthma exacerbation frequency
时间窗: from baseline to 12 weeks
Asthma exacerbation frequency
Spirometry
时间窗: from baseline to 12 weeks
Forced Expiratory Volume in 1 second (FEV₁) - L or % predicted
Frequency of rescue medication use
时间窗: from baseline to 12 weeks
Frequency of Asthma Inhalers used
Change in asthma control
时间窗: from baseline to 12 weeks
Change in Asthma Control Test (ACT) Score (points; range 5-25)
次要结局
- Lipid Profile(From baseline to 12 weeks)
- Anthropometric Measurements(From baseline to 12 weeks)
- Incidence of Treatment-Emergent Adverse Events(Monthly from baseline to 3 months)
研究者
Amani Mohamed
Lecturer of Clinical Pharmacy
Cairo University